On January 26, 2023, Principal Deputy Commissioner Janet Woodcock released a statement regarding the current state of cannabidiol (CBD) regulation by the FDA and a growing need for a “new […] Read More >>
On January 31, 2023, the Commissioner of the Food and Drug Administration, Dr. Robert Califf, announced a proposal to overhaul the human foods program to protect food safety. The statement, […] Read More >>
A CRO, or Contract Research Organization, is an outsourced service provider that manages clinical trials. CROs are designed to help make research more feasible. It should then come as no […] Read More >>
Health Canada is proposing expanding the Terms and Conditions (T&Cs) on Class II to IV medical device licences to support the life cycle approach for regulating medical devices. This is […] Read More >>
The FDA has recently announced a proposal to amend the current Investigational New Drug (IND) application regulations. The proposal involves 2 exemptions for clinical investigations involving lawfully marketed foods (including […] Read More >>
On December 20, 2022, the Federal Trade Commission (FTC) published “Health Products Compliance Guidance” for advertising and marketing health claims. The guidance document replaces “Dietary Supplements: An Advertising Guide for […] Read More >>
On November 21, 2022, the FDA’s Center for Food Safety and Applied Nutrition issued warning letters to five manufacturers of food and beverages containing cannabidiol (CBD). These letters mark the […] Read More >>
Real-world data (RWD) and real-world evidence (RWE) are becoming an integral part of health care decisions such as in the approving process, in clinical practice, in generating innovative, and new […] Read More >>
On Thursday, November 17, 2022, the Center for Food Safety and Applied Nutrition issued seven warning letters to manufacturers of supplements marketed for the promotion of cardiovascular health. The dietary […] Read More >>
The days of using pot at work could be coming to an end, thanks to portable headsets being rolled out that track an employee’s eye movements and assess whether they […] Read More >>
A novel cannabis intoxication testing device developed by Montana tech company Gaize, Inc. detected irregular eye movement in hundreds of subjects who consumed cannabis in a recent clinical trial. On […] Read More >>
dicentra, a leading Contract Research Organization (CRO) and global consulting firm is proud to congratulate their client, Gaize, Inc. as they announced completion of the world’s largest clinical trial investigating cannabis […] Read More >>
The FDA recently published responses to several new dietary ingredient notifications (NDIN) submitted for nicotinamide mononucleotide (most notably the November 8, 2022 response to Inner Mongolia Kingdomway Pharmaceutical Ltd. “Kingdomway”). […] Read More >>
dicentra, a leading Contract Research Organization (CRO) and Global Consulting firm, is pleased to announce the appointment of veteran financial executive Alka Sood as the new Chief Financial Officer (CFO), […] Read More >>
dicentra, a leading Contract Research Organization (CRO) and global consulting firm for the life sciences and food industries, is pleased to announce that Hala Mousa, a Regulatory Affairs Manager at […] Read More >>
Monkeypox, the disease caused by the animal-to-human transmission of the Monkeypox virus, is a zoonosis of the Orthopoxvirus genus within the Poxviridae family. Usually endemic to regions of central and […] Read More >>
dicentra, a leading Contract Research Organization (CRO) and global consulting firm is proud to congratulate their client, Allerpops who just wrapped up clinical trials of its flagship product — lollipops […] Read More >>
To be used in foods and dietary supplements, ingredients must: be determined to be Generally Recognized as Safe (GRAS), be approved as a New Dietary Ingredient (NDI), be considered an […] Read More >>
Bringing a drug or a natural health product to market in Canada involves applying for an 8-digit numerical code, called a DIN for drugs, or an NPN for natural health […] Read More >>
dicentra, a world-renowned Contract Research Organization (CRO) and global consulting firm is proud to congratulate their client, Allerpops, who has completed enrolment on their phase II clinical trial on allergic […] Read More >>